Quality Specialist, Project Manager
Edison-New Brunswick Metro Area, NJ
The Global Product Quality Specialist, Project Manager will be responsible for planning and leading implementation of multiple projects across global product quality. More specifically they will be managing (and owning as needed) documentation and change controls associated with key deliverables to clinical and commercial documentation across multiple programs. We are looking for someone who can keep track of multiple work streams and collaborate across multiple functions (i.e. Site QA/QC, manufacturing, validation, IT, manufacturing science and technology, analytical development, etc.) to ensure all technical and compliance requirements are met per clinical and commercial development timelines. Follows-up to verify completion of activities. Provides assistance to other Global Product Quality staff members as needed. Performs other QA duties as assigned.
Minimum of 5-7 years of demonstrated success implementing complex business or technology initiatives. Minimum of 3 years working under GMP conditions. BA or BS degree.
Detail oriented with high degree of focus. Able to follow instructions and procedures, both written and verbal.
Able to understand complex work practices.
Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
Strong written, verbal, and organizational skills, and ability to work in inter-disciplinary and cross-functional teams.
Scientific background with basic understanding of typical analytical methods and Quality Control
Able to perform with minimal supervision and contribute in a team environment.
Experience with eQRMS, electronic documentation systems (Veeva), and other quality systems.
Basic knowledge and ability in using Microsoft Office Package.
Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of biological products.